Testing for microorganisms and heavy metals in cosmetics is an important step in ensuring product safety and quality. These contaminants may lead to skin infections, allergies and other problems. Therefore, in order to protect the health of consumers, countries have set limits on the content of microorganisms and heavy metals in cosmetics in order to maintain the effectiveness and stability of the products. This article summarizes the requirements of China, the European Union, ASEAN, the United States, and Taiwan, China in this regard.
China
The Technical Specifications for Safety of Cosmetics (2015 Edition) issued by China clarifies the limit standards and detection methods for microorganisms and heavy metals in cosmetics. Later, in 2019, NMPA issued the Cosmetics Registration and Filing Inspection Work Specifications, which further clarified the applicable scope of products that require microbiological inspection items for cosmetics registration or filing.
Microbial specific limits
Heavy metal restriction requirements
The European Union
According to the EU Cosmetics Regulation (EU Regulation 1223/2009), all cosmetics sold in the EU market must undergo microbiological evaluation.
Referring to SCCS/1628/21 "11th Edition of the Guidelines for Testing and Safety Assessment of Cosmetic Ingredients", the EU divides cosmetics into two categories in terms of microbial limits:
❑ Products for children under three years old, eyes or mucous membranes.
❑ Other products.
Microbial specific limits
Heavy metal restriction requirements
All cosmetics sold in the EU market must not contain substances listed in Annex II of the EU Cosmetics Regulation (EU Regulation 1223/2009), including lead, cadmium, arsenic, mercury, antimony and their compounds, but the special case of preservatives in Annex V is not included. There is no specific regulation on the limit of heavy metals, which can be referred to the limit requirements of the specific country of export.
ASEAN
The ASEAN Cosmetic Contamination Limit Guidelines (VERSION 3.0) stipulates the microbiological limits and heavy metal limit requirements for cosmetics. In addition, the ASEAN Cosmetic Microbial Limit Test (ACMTHA06) stipulates the method for counting aerobic bacteria, yeasts and molds in cosmetics, but there is no regulation requiring the use of this method, so other methods can also be used to detect microorganisms.
Microbial specific limits
Heavy metal restriction requirements
The United States
The U.S. FDA has no specific microbial testing regulations for cosmetics, but only emphasizes product safety and good manufacturing practices. Therefore, many manufacturers will conduct microbial testing on their own to prevent potential risks.
Microbial specific limits
In addition, some industry associations also provide guidance standards for microbial testing, such as the Microbiology Guidelines 2021 issued by the American Personal Care Products Association (PCPC), which stipulates the following microbial limits:
Heavy metal restriction requirements
According to the FDA Testing of Arsenic, Cadmium, Chromium, Cobalt, Lead, Mercury and Nickel in Cosmetics issued by the US FDA in 2022, the specific restrictions on heavy metals in US cosmetics are as follows:
Taiwan, China
The List of Microbial Limits for Cosmetics issued by the Food and Drug Administration of the Ministry of Health and Welfare of Taiwan in 2022 stipulates the microbial limits for cosmetics sold in Taiwan. In addition, the Food and Drug Administration of the Ministry of Health and Welfare of Taiwan updated the List of Prohibited Ingredients in Cosmetics in March 2024, but the heavy metal limit requirements have not changed.
Microbial specific limits
Heavy metal restriction requirements
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